Anavex Life Sciences Corp (AVXL)

[nidan7500]

Cannot help but ponder on how much/any BIOMARKER TRACE correlation data (see most recent Patent APPhttps://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220220142968%22.PGNR.&OS=DN/20220142968&RS=DN/20220142968-). Dr.M. and staff have been able to gather from the PDD OLE work. Possibly this opportunity provided the/some inspiration along process line....HMMMMM, WHAT IF WE ....fill in the blanks...NICE THOUGHT.

The 48 week OLE (open label extension) PDD trial results will be completed by or before the end of June 2022 and I bet the results will be substantially better than the 14 week PDD Phase 2 results.

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the presentation of Phase 2 clinical biomarker data from the ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia (PDD) study at AD/PD™ 2022 International Conference on Alzheimer’s & Parkinson’s Diseases and related neurological disorders, taking place in Barcelona, Spain, and virtually on March 15–20, 2022.

The poster presentation titled, “ANAVEX®2-73 (blarcamesine) - Analysis of Movement (MDS-UPDRS) and Cognitive (CDR System) Pharmacodynamic-Biomarker Outcome Measures of Placebo-Controlled Phase 2 Trial in 132 Parkinson’s Disease Dementia Patients” is being presented by the Principal Investigator of the trial, Dr. Jaime Kulisevsky, MD, PhD, Full Professor of Neurology & Vice-Dean Faculty of Medicine Autonomous University of Barcelona and Director of the Movement Disorders Unit, Department of Neurology, Sant Pau Hospital.

MDS-UPDRS[1] Total score improved significantly by -14.51 (p=0.034) for patients treated with ANAVEX®2-73 high oral once-daily dose compared to placebo. The improvement is clinically relevant corresponding to a relative improvement of 18.9% over 14 weeks.

Balanced and global improvements were observed within all MDS-UPDRS sub-scores Part I-IV:
• MDS-UPDRS Part I: 92.23% items improved (12 items out of 13)
• MDS-UPDRS Part II: 76.92% items improved (10 items out of 13)
• MDS-UPDRS Part III: 88.23% items improved (30 items out of 34)
• MDS-UPDRS Part IV: 71.42% items improved (5 items out of 7)

MDS-UPDRS Total score is defined by the sum of all Parts:
• Part I: Non-motor Experiences of Daily Living
• Part II: Motor Experiences of Daily Living
• Part III: Motor Examination
• Part IV: Motor Complications

SIGMAR1 mRNA expression significantly increased in ANAVEX®2-73-treated patients vs placebo (p=0.035) over the course of treatment and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.

Dr. Jaime Kulisevsky, MD, PhD, Principal Investigator of the trial, commented, "PDD is a debilitating disorder with significant co-morbidities and there has not been a mechanistically novel medication approved for PDD in over 20 years. Hence, new therapies are urgently needed to alleviate this suffering and disability. I am impressed with the robust improvement of the MDS-UPDRS across all sub-score parts I-IV coupled with the biomarker correlated outcome measures and I support the implementation of the ANAVEX®2-73 Phase 3 studies in Parkinson's disease and Parkinson's disease dementia, respectively.”

Christopher U Missling, PhD, President & Chief Executive Officer of Anavex, remarked, "ANAVEX®2-73 (blarcamesine) demonstrated dose-dependent efficacy for both motor impairment (MDS-UPDRS) and cognition (CDR system), which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively. These results support continued development of ANAVEX®2-73 in Parkinson’s disease and Parkinson’s disease dementia as well as currently ongoing Precision Medicine biomarker-driven late-stage clinical studies in Rett syndrome and Alzheimer’s disease. We would like to thank all the patients and participating families as well the investigators and clinical site coordinators for their dedication to this study."

https://79bcf7a1-8b8e-483b-b7cf-f5c5192a6d63.usrfiles.com/ugd/79bcf7_ff6b864593fb4418ab306474dd535d35.pdf

https://www.anavex.com/post/anavex-life-sciences-announces-presentation-of-phase-2-clinical-biomarker-data-from-pdd-study